Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey

Completed

Conditions: High Cholesterol
Prostate Cancer
High Blood Pressure
Breast Cancer
Colorectal Cancer

Registration Number: NCT04317690

Lead Sponsor: Massachusetts General Hospital

Brief Summary: The purpose of this study is to survey a sample of adults who have recently made a decision about treatment of high cholesterol or high blood pressure or a decision about screening for colorectal cancer, breast cancer, or prostate cancer. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions for these common medical situations.

Detailed Description: Study staff worked with a national sampling firm to recruit subjects for five different medical decisions. The five decisions are (1) treatment of high cholesterol, (2) treatment of high blood pressure (3) when to start breast cancer screening (4) whether or not to have prostate cancer screening and (5) which test to have for colorectal cancer screening. Respondents complete a survey about their experiences talking with health care providers about the specific clinical decision. The survey measured the amount of shared decision making, knowledge, preferences, decisional conflict and decision regret. The study will obtain 500 responses total, or 100 for each decision.

Sample is an online non-probability panel of adults living in the United States. In the survey, participants were screened to meet specific qualifications. After 1 week, a random selection of 50 respondents are invited to complete the retest instrument.

All analyses will be conducted separately for each group, and results may be pooled across cancer screening and medication contexts. First, study staff will examine the descriptives for the Shared Decision Making Process items. Study staff will also test several hypotheses to examine validity of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret. Staff will also examine retest reliability of the Shared Decision Making Process scale.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 539

Inclusion Criteria

High Blood Pressure Group

Between the ages of 30-75
No previous heart attack or stroke
Have been diagnosed with high blood pressure
Taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years

High Cholesterol

Between the ages of 30-75
No previous heart attack or stroke
Have been diagnosed with high cholesterol
Taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years

Colorectal Cancer Screening

Between the ages of 50-75
No previous diagnosis of colon cancer
Have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years
Had first colon cancer screening in past 2 years

Breast Cancer Screening

Female
Between the ages of 40-55
No previous diagnosis of breast cancer
Have had mammogram (or discussed having a mammogram) in the past 2 years
Had first mammogram in past 2 years

Prostate Cancer Screening

Male
Between the ages of 45-69
No previous diagnosis of prostate cancer
Have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years
Had first prostate cancer screening in past 2 years

Exclusion Criteria

High Blood Pressure Group

None

High Cholesterol

None

Colorectal Cancer Screening

None

Breast Cancer Screening

None

Prostate Cancer Screening

None

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shared Decision Making Process Measure	Baseline survey	The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.

Secondary Outcome Measures

Name	Time	Method
Shared Decision Making Process Measure Retest	1 week after baseline survey	The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.
Knowledge	Baseline survey	Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge
Decision Regret Scale	Baseline survey	5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.
Adapted Controlled Preference Scale	Baseline survey	Single item asking the participant who made the ultimate decision. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together.
Treatment Choice	Baseline survey	Single item asking patient "What did you want to do" in regard to (depending on the group) high cholesterol/high blood pressure/colon cancer screening/breast cancer screening/prostate cancer screening
Decisional Conflict Tool (SURE)	Baseline survey	Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates no decisional conflict, and scores 1 to 3 indicate decisional conflict. The measure is often reported as a top-score of 0, thus the percentage of patients with a total score of 0 or no decisional conflict.
Single-Item Measure of Decision Regret	Baseline survey	Single item asking "If you knew then what you know now, do you think you would make the same decision about \[how to manage your high cholesterol/ how to manage your high blood pressure/breast cancer screening/colon cancer screening/ prostate cancer screening\]?" where the last part varies by group. Response options are: Definitely yes, Probably yes, Probably no, Definitely no